MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number SAT001

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a smartablate¿ irrigation tubing set and a bubble-like material was loose in the tubing.Initially reported in both tubes, bubbles/plasticizer-like substance could not be removed even after flushing.Reported poor tubing.The issue was noted when the tube was connected.The bubble was confirmed by the pump in overall including directly under the sensor and from upper to lower of pump.Error was absent at the pump.The issue was resolved by replacing the tubing set to another new one.The procedure was successfully completed without patient consequence.Additional information was received on 13-feb-2024.The issue was detected during the first flush.The tubing was connected to the pump.The customer flushed the tubing before using in the patient.The bubbles were detected after passing through the pump sensor.No error.It is unknown whether the material observed was bubbles or plasticizer-like material.No foreign material / plastic substance / particles moving inside the tubing.Additional information was received on 03-mar-2024.The bubble-like material was loose in one tubing and was embedded in the other tubing; however, it was unable to distinguish which was which.This event was originally considered non-reportable, however, bwi became aware of the bubble like material was loose in one tubing on 03-mar-2024 and have reassessed the event under this tubing as reportable with the reportable awareness date of 03-mar-2024.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 11-apr-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a procedure with a smartablate¿ irrigation tubing set.In both tubes, bubbles/plasticizer-like substance could not be removed even after flushing.Reported poor tubing.The issue was noted when the tube was connected.The bubble was confirmed by the pump in overall including directly under the sensor and from upper to lower of pump.Error was absent at the pump.The issue was resolved by replacing the tubing set to another new one.The procedure was successfully completed without patient consequence.Additional information was received.The issue was detected during the first flush.The tubing was connected to the pump.The customer flushed the tubing before using in the patient.The bubbles were detected after passing through the pump sensor.It is unknown whether the material observed was bubbles or plasticizer-like material.No foreign material/plastic substance / particles moving inside the tubing.The bubble-like material was loose in one tubing and was embedded in the other tubing; however, it was unable to distinguish which was which.The device evaluation was completed on 26-apr-2024.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and irrigation test of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned sample revealed that the inner diameter of the device was cloudy; no other damage or anomalies were observed.Irrigation test was performed and bubbles with no movement were observed during the test.A device history record evaluation was performed and no internal actions related to the complaint was found during the review.The cloudy and bubbles could be related to the issue described by the customer; therefore, the complaint was confirmed.Bubbles reported may be related to a known plasticizer migration phenomenon of pvc materials and has no interference with the functionality of smartablate pump.Bubbles on the smartablate tubing have been investigated by a cross functional team and the engineering analysis suggests that a plasticizer migration in the tubing product may be contribute to a change in tubing appearance including opacity, increase in lumen roughness as well as microbubble adhesion.Plasticizer migration is a known phenomenon in softer polyvinyl chloride (pvc) materials like our tubing set.Additionally, an independent evaluation determined that the plasticizer is not toxic and will not result in adverse health effects in cardiac ablation patients under normal use conditions.Despite any change in tubing appearance, bubbles in the saline remain readily detectable.In addition, the bubble sensor on the smartablate pump uses ultrasound signals and the sensitivity of this sensor is unaffected by any change in tubing appearance.Customers should continue to properly prime and flush tubing per the instructions for use (ifu) and the smartablate irrigation tubing set preparation workflow.An internal corrective action has been opened to reduce this failure mode introduce optimization actions on devices with cloudiness and microbubbles.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): LAKE REGION MEDICAL; 31-c butterfield trail; el paso TX 79906 0000
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18984406
• MDR Text Key: 338681941
• Report Number: 2029046-2024-01028
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAT001
• Device Lot Number: AC8572241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE IRR TUBE SET; UNK PUMP